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Just caught that BridgeBio's (BBIO) stock is having a solid day after their achondroplasia trial data dropped. The PROPEL 3 results look pretty solid for infigratinib - kids on the drug showed about 1.74 cm/year more growth compared to placebo, which honestly is the kind of improvement you want to see in dwarfism treatment. They're talking about filing with the FDA in the second half of this year.
What's interesting is the timing here. Ascendis has their own drug in the mix and already hit their PDUFA date target action date back in February, so that's already in motion. BioMarin got Voxzogo approved years ago, so the competitive pressure is real. But if BridgeBio's data holds up, they could have a meaningful option in this space.
Stock's up almost 7% and sitting around $78 right now, pretty close to that 52-week high of $84.94. The real test will be what the regulators think when they review the NDA. The PDUFA target action date process usually takes a few months, so we're probably looking at late 2026 or early 2027 for a decision if everything goes smooth. Tolerability looked good too - no serious drug-related issues in the trial, which is always a plus for rare disease treatments.